Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529848
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries INOCA The ExINOCA Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ischemia With No Obstruction of Coronary Arteries Underlying Mechanisms and the Impact of Exercise Training EXINOCA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExINOCA
Brief Summary:
The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart and to investigate whether physical exercise can improve coronary microvascular function
Hypotheses
The first hypothesis is that in INOCA with reduced function of microvasculature of the heart this reduced function also occurs in other organs of the body
The second hypothesis is that regular physical activity aerobic exercise training can improve coronary microvascular function reduce symptoms and that there is a parallel improvement in vascular function in other organs of the body
Hypotheses
The first hypothesis is that in INOCA with reduced function of microvasculature of the heart this reduced function also occurs in other organs of the body
The second hypothesis is that regular physical activity aerobic exercise training can improve coronary microvascular function reduce symptoms and that there is a parallel improvement in vascular function in other organs of the body
Detailed Description:
A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these their symptoms are attributed to coronary microvascular dysfunction CMD a condition known as ischemia with no obstructive coronary artery disease INOCA Despite a considerable patient population affected by INOCA the specific mechanisms underlying CMD are not fully understood often resulting in a lack of targeted treatment There is evidence to suggest that exercise capacity is linked to coronary microvascular function positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins a hypothesis yet to be explored
This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition
The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD 100 patients will be randomized 11 to exercise training or control The primary outcome is coronary microvascular function secondary outcomes include symptoms and microvascular function in cutaneous tissue skeletal muscle and adipose tissue
This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition
The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD 100 patients will be randomized 11 to exercise training or control The primary outcome is coronary microvascular function secondary outcomes include symptoms and microvascular function in cutaneous tissue skeletal muscle and adipose tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None